[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.276]



[Page 25-26]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents

 

                 Subpart I_Prior Notice of Imported Food

 

Sec.  1.276  What definitions apply to this subpart?



    Source: 68 FR 59070, Oct. 10, 2003, unless otherwise noted.



                           General Provisions





    (a) The act means the Federal Food, Drug, and Cosmetic Act.

    (b) The definitions of terms in section 201 of the act (21 U.S.C. 

321) apply when the terms are used in this subpart, unless defined 

below.

    (1) Calendar day means every day shown on the calendar.

    (2) Country from which the article originates means FDA Country of 

Production.

    (3) Country from which the article is shipped means the country in 

which the article of food is loaded onto the conveyance that brings it 

to the United States or, in the case of food sent by international mail, 

the country from which the article is mail.

    (4) FDA Country of Production means:

    (i) For an article of food that is in its natural state, the country 

where the article of food was grown, including harvested or collected 

and readied for shipment to the United States. If an article of food is 

wild fish, including seafood that was caught or harvested outside the 

waters of the United States by a vessel that is not registered in the 

United States, the FDA Country of Production is the country in which the 

vessel is registered. If an article of food that is in its natural state 

was grown, including harvested or collected and readied for shipment, in 

a Territory, the FDA Country of Production is the United States.

    (ii) For an article of food that is no longer in its natural state, 

the country where the article was made; except that, if an article of 

food is made from wild fish, including seafood, aboard a vessel, the FDA 

Country of Production is the country in which the vessel is registered. 

If an article of food that is no longer in its natural state was made



[[Page 26]]



in a Territory, the FDA Country of Production is the United States.

    (5) Food has the meaning given in section 201(f) of the act,

    (i) Except for purposes of this subpart, it does not include:

    (A) Food contact substances as defined in section 409(h)(6) of the 

act (21 U.S.C. 348(h)(6)); or

    (B) Pesticides as defined in 7 U.S.C. 136(u).

    (ii) Examples of food include fruits, vegetables, fish, including 

seafood, dairy products, eggs, raw agricultural commodities for use as 

food or as components of food, animal feed (including pet food), food 

and feed ingredients, food and feed additives, dietary supplements and 

dietary ingredients, infant formula, beverages (including alcoholic 

beverages and bottled water), live food animals, bakery goods, snack 

foods, candy, and canned foods.

    (6) Grower means a person who engages in growing and harvesting or 

collecting crops (including botanicals), raising animals (including 

fish, which includes seafood), or both.

    (7) International mail means foreign national mail services. 

International mail does not include express carriers, express 

consignment operators, or other private delivery services.

    (8) No longer in its natural state means that an article of food has 

been made from one or more ingredients or synthesized, prepared, 

treated, modified, or manipulated. Examples of activities that render 

food no longer in its natural state are cutting, peeling, trimming, 

washing, waxing, eviscerating, rendering, cooking, baking, freezing, 

cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 

milling, grinding, extracting juice, distilling, labeling, or packaging. 

Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled 

attendant to harvest or collection or treated against pests, waxed, or 

polished are still in their natural state for purposes of this subpart. 

Whole fish headed, eviscerated, or frozen attendant to harvest are still 

in their natural state for purposes of this subpart.

    (9) Port of arrival means the water, air, or land port at which the 

article of food is imported or offered for import into the United 

States, i.e., the port where the article of food first arrives in the 

United States. This port may be different than the port where 

consumption or warehouse entry or foreign trade zone admission 

documentation is presented to the United States Bureau of Customs and 

Border Protection (CBP).

    (10) Port of entry, in sections 801(m) and 801(l) of the act, means 

the port of entry as defined in 19 CFR 101.1.

    (11) Registration number refers to the registration number assigned 

by FDA under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1, 

subpart H.

    (12) Shipper means the owner or exporter of the article of food who 

consigns and ships the article from a foreign country or the person who 

sends an article of food by international mail to the United States.

    (13) United States means the Customs territory of the United States 

(i.e., the 50 states, the District of Columbia, and the Commonwealth of 

Puerto Rico), but not the Territories.

    (14) You means the person submitting the prior notice, i.e., the 

submitter, or the person transmitting prior notice information on behalf 

of the submitter, i.e., the transmitter.



[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]